MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 5MM4CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	4400504S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a powerflex pro 5mm4cm 80 was used for pre-dilation; however, it ruptured.There were no reported patient injuries.The device was replaced with a same sized non-cordis new balloon catheter and the procedure was completed.The target lesion was the iliac artery.The device was discarded due to suspicious infectious disease.The device was stored on the shelf in the cath lab.The device was stored in the cath lab for one month.The device was stored, handled and prepped per the instructions for use (ifu).The device was prepped normally by maintaining negative pressure.There was no difficulty removing the product from the hoop or removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.The same indeflator was used successfully with other devices.There were no kinks or other damages noted prior to inserting the product into the patient.The balloon catheter was removed easily and intact.The lesion was moderately calcified, with little vessel tortuosity.
Additional Manufacturer Narrative
A powerflex pro 5mm x 4cm x 80cm was used for pre-dilation; however, it ruptured.There were no reported patient injuries.The device was replaced with a same sized non-cordis new balloon catheter and the procedure was completed.The target lesion was the iliac artery which was moderately calcified, with little vessel tortuosity.The device was stored on the shelf in the cath lab for one month.The device was stored, handled and prepped normally per the instructions for use (ifu).There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.The same indeflator was used successfully with other devices.There were no kinks or other damages noted prior to inserting the product into the patient.The balloon catheter was removed easily and intact.The product was not returned for analysis.A product history record (phr) review of lot 82166089 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.However, without return of the product for analysis, it is difficult to draw a clinical conclusion between the device and the reported event.Vessel characteristics of moderate calcification may have contributed to the reported event, as it is known that calcium may damage balloon material.According to the safety information in the instructions for use ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.Balloon pressure should not exceed the rated burst pressure.The rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence), will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over pressurization.Use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate the balloon.Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

• Brand Name: POWERFLEXPRO 5MM4CM 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8952474
• Report Number: 9616099-2019-03184
• Device Sequence Number: 11434965
• Product Code: LIT
• UDI-Device Identifier: 20705032059326
• UDI-Public: 20705032059326
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 4400504S
• Device Lot Number: 82166089
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER (BOSTON SCIENTIFIC)